RecruitingNot ApplicableNCT04107948

Efficiency of an Optimized Care Organization for Fibromyalgia Patients. The FIMOUV 2 Study

Efficiency of an Optimized Care Organization for Fibromyalgia Patients Within the Group of Hospitals of Loire Territory. Interventional Study Aimed at Changing Behaviour in Terms of Physical Activity and Sedentary


Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrollment

330 participants

Start Date

Jan 23, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Fibromyalgia affects 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest. The diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest. Thus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (Level 1, Grade A). The question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Patient diagnosed with fibromyalgia according to ACR (American College of rheumatology) criteria (total score WPI (Widespread Pain Index) + SS (Severity Scale) ) ≥ 13
  • French writing and speaking
  • Sedentary or low level of activity (less than 150 minutes of regular physical activity per week at the time of inclusion)
  • Signature of informed consent

Exclusion Criteria3

  • Cardiac or respiratory diseases that contraindicate the practice of physical activity
  • Significant co-morbidities that contraindicate the practice of physical activity: associated cardiac pathologies (severe rhythm disorders such as rapid atrial fibrillation), respiratory pathologies (severe obstructive or severe respiratory insufficiency), disabling joint pathologies (knee osteoarthritis or osteoarthritis of the hip) training on a treadmill or on a high intensity bike).
  • Impossibility of submitting to the medical monitoring of the program for geographical, social or psychological reason

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Interventions

OTHERphysical activity program

Two weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified "Sports Health" in the Loire (42), Haute-Loire (43) or Ardèche (07) for 2 months.

OTHERAdvice and recommendations of physical activity at home

Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).


Locations(7)

CH d'ANNONAY

Annonay, France

CH de Firminy

Firminy, France

CH de MONTBRISON

Montbrison, France

CH de Rive de Gier

Rive-de-Gier, France

CH de ROANNE

Roanne, France

CH du Gier

Saint-Chamond, France

Chu Saint Etienne

Saint-Etienne, France

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NCT04107948


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